What is Enterra?
Enterra is used in the treatment of Gastroparesis. Gastroparesis is a condition where the stomach does not empty very effectively. Because of this, stomach contents can remain there for long periods of time. This can cause symptoms such as: nausea, vomiting, weight loss, decreased appetite, a full feeling in the abdomen, or the feeling that you are full after eating only a few bites.
Enterra is a device much like a pacemaker. It is an electric stimulator that is used to stimulate the stomach muscle with the goal of improving stomach emptying. If effective it eliminates the symptoms noted above.
Enterra Therapy consists of:
- A Neurostimulator (generator similar to a cardiac pacemaker). This is the part of the device that sends a message to the stomach to contract. It also contains the battery.
- Leads (coated wires with special sensors on both ends) this part of the device carries the message to the stomach telling it to contract.
- Programmer is the computer that is used to program the amount of energy and frequency of signals used to stimulate the stomach muscle.
The generator is surgically placed in the lower abdominal region just beneath the skin. One end of the lead is placed in the muscle wall of the stomach. The other end of the lead is attached to the stimulator. The programmer is then used to identify the amount of energy needed to stimulate the stomach and to program amount and frequency of signals to be sent to the stomach muscle. Adjustments can be made with the programmer in the office at future visits this allows adjustments (fine-tuning) to be made in our office without any discomfort to you.
There are different causes for Gastroparesis. It frequently occurs in individuals with diabetes, and may occur in other people after intestinal surgery, stomach infections, or with certain neurological problems. It can also occur spontaneously.
Prior to receiving Enterra Therapy, a person is evaluated by a gastroenterologist that specializes in the treatment of Gastroparesis with Enterra. If it is determined that your symptoms are caused by failure of your stomach muscles to contract and empty you may be a candidate for this therapy. If your symptoms are due to something else, further evaluation and treatment should be done.
You may have had previous treatments for your nausea, vomiting and related symptoms. These may have included changes in your diet, or medications, or adding medications that are used to stimulate gastric emptying. You may have even had feeding tubes placed into your stomach or small intestine for nutritional support. You may have been hospitalized for IV hydration and nutrition and received medications to control your nausea.
Even if these measures have failed, you may be an excellent candidate for Enterra therapy. Currently the use of Enterra therapy is limited to those people who have failed all other treatments and who have had symptoms for 12 months.
When Enterra has been used in carefully selected patients’ studies have shown that 70-90% had significant reduction in their symptoms of nausea and vomiting. Enterra has also been shown to reduce hospitalizations and medical costs.
How do I get ready for this Procedure?
You will need to have some diagnostic tests prior to our advising you to consider Enterra therapy. If you have already had some of these tests, they will need to be reviewed by our gastroenterologists who specialized in Enterra therapy. The following are tests and evaluations that need to be done before recommending Enterra therapy:
- 30-minute consultation with the Enterra specialist. This consult involves reviewing your history and prior medical tests. If we did not order these tests, it would be helpful for you to bring any x-rays and reports of prior tests.
- Upper Endoscopy
- Solid Phase Gastric Emptying Study or SmartPill Study
- Blood Tests which may including: Complete Blood Count, Electrolytes and blood sugar, Thyroid tests, Calcium, Liver and Kidney Panels, H. Pylori.
- CT. Scan of the abdomen
- Ultrasound of the gallbladder
- X-ray of the small intestine
Other preparations include: a period of time off of any medications that might be causing symptoms, i.e.
- All herbs, vitamins and nonessential medications.
- Aspirin and any related medications (i.e. Motrin, Ibuprofen, Naprosyn, etc.)
- Narcotic pain medications
- Some heart-related medications (if possible and with the approval of your doctor).
- You may be placed on a trial of Reglan or Erythromycin in combination with an acid reducing medication.
- If you are a diabetic your blood sugars need to be in good control.
Once these tests are completed, you will meet with the Physician Assistant or Nurse Practitioner that works with the Enterra Therapy Team. They will review the results with you and will go over the Informed Consent process. Together we will decide if Enterra is appropriate for you. People who have had prior surgery on the stomach itself or have had placement of a feeding tube through the stomach wall may not be appropriate for the Enterra device. Several other conditions or medical problems may limit your ability to have Enterra therapy. We must all agree that your chance of feeling better with Enterra is high. If it is decided to proceed with Enterra, you will be referred to the surgeon who places the stimulator.
Where is the Surgery done?
The surgeon and their staff will make the necessary arrangements for your admission to the appropriate hospital. You should anticipate a 2-3 day stay. The surgeon will discuss with you what will happen during surgery and the hospitalization period. You will need approval from both your insurance company and the participating hospital prior to scheduling surgery. Our office will help you with the insurance approval. The surgeon will work with you to obtain approval form the hospital.
What will I feel like after surgery?
You will have some mild incision discomfort for 1-3 weeks after surgery. You may feel somewhat tired the day after surgery due to the anesthesia. After a recovery period of 1-2 weeks, you should expect to feel well from a physical standpoint. There will be and ongoing process of making adjustments to your stimulator's settings to give you the best results.
What are the risks?
Complications are rare (approximately 5%). But have included infections and perforations (punctures or holes) in the stomach. We have placed several devices with excellent results in most people. Based on these results, the Food and Drug Administration has granted Enterra a "Humanitarian Device Exemption". This means that the FDA recognizes that Enterra is helpful, but it does not have enough proof to allow unrestricted use. Therefore, we must obtain prior approval for its use from your insurance company and the participating hospital. Once a year the Institutional Review Board at the hospital looks at our results and determines whether we are using Enterra appropriately.
How do I take care of the Enterra device?
The surgeon will give you instructions on how to care for your incision. Apart from this, there will be regularly scheduled follow-up appointments to see how you are doing and to check your battery status. Because the device is metallic, you will need to obtain a medical information card that identifies you as having an implantable device. This is important if you travel, as the device may set off airport security systems.
What kind of follow-up will be necessary?
After discharge from the hospital, you will see the surgeon for routine follow-up. You will also need to schedule an appointment with the Enterra team for follow-up and programming of your Enterra device. Further follow-up information will be given at this appointment.
When do I need to call the doctor?
Once you are home from the hospital, if you are having signs of infection (fever, redness at the incision site, increased pain or drainage from your incision, call your surgeon. If you are continuing to have problems with nausea and vomiting, call your office at 612-871-1145.
Is there anything else that I should know?
It is important that you have a primary physician helping you with all your health care needs unrelated to the Enterra device. Our team works strictly in a consultant capacity to your primary physician. Your other health care needs should be monitored and evaluated by your primary physician.
If you have any questions, please call our office at (612) 871-1145.
